MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PICC SET: 16 GA X 27 1/2IN; CATHETER INTRAVASCULAR THERAPE

Catalog Number	AJ-01671
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Difficult to Advance (2920); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the user felt a resistance when inserting the swg through the catheter.Therefore, the catheter and the swg were removed and replaced with a new kit.No harm to the patient occurred.
Event or Problem Description
It was reported that the user felt a resistance when inserting the swg through the catheter.Therefore, the catheter and the swg were removed and replaced with a new kit.No harm to the patient occurred.
Additional Manufacturer Narrative
Qn#(b)(4).The report of a kinked guide wire due to resistance within the catheter was confirmed through complaint investigation of the returned sample.The customer returned one, opened picc kit for analysis.The guide wire and the picc catheter will be analysed as part of this complaint investigation.No definite signs-of-use were observed.Visual analysis revealed that the guide wire contained one kink towards the proximal end.Microscopic examination confirmed the damage to the guide wire and revealed that the distal and proximal welds were spherical and intact.It was also observed after functional testing that the catheter body was elongated in the middle of the extrusion.This elongation likely contributed to the resistance encountered by the customer.No signs of stretching were observed on the catheter markings, which indicates that the stretching likely occurred before the markings were applied.The kink on the guide wire measured 51mm from the proximal end.The guide wire total length measured approximately 100cm, which was within the spe cification limits of 99.4cm-113cm per the guide wire product drawing.The kink and the guidewire total length were measured via calibrated ruler.The guide wire outer diameter measured.0345" via calibrated caliper, which was within the specification limits of.03 40"-.0355" per the guide wire product drawing.The elongated portion of the catheter body measured 80mm-135mm, from the juncture hub.The catheter body total length from the juncture hub to the distal tip measured 28 3/4", which was within the specification limits of 27 9/16"-29 9/16" per the catheter product drawing.The catheter body length was measured via calibrated ruler.The catheter body outer diameter (in an area not affected by elongation) measured.0700", which was within the specification limits of.0655"-.0705" per the catheter extrusion product drawing.The catheter body outer diameter in the area affected by elongation measured.060", which was not within the specification limits of.0655"-.0705" per the catheter extrusion product drawing.The catheter body outer diameter was measured via calibrated caliper.Functional inspection was performed per ifu statement, "thread catheter over guidewire and advance catheter over guidewire to final indwelling position using image guidance or fluoroscopy".The guide wire was inserted through the catheter body and major resistance was encountered when the guide wire reached the elongated portion of the catheter extrusion.This elongation prevented the guide wire from passing.The guide wire seemed to pass through all other sections of the guide wire with little to no resistance.Additionally, the ifu provided with the kit informs the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained, and further consultation requested." a device history record review was performed, and no relevant findings were identified.Based on the customer report, the sample received, and the past comments from manufacturing, the observed defect likely occurred during the extrusion process.Further investigation has been initiated under teleflex's quality system by the manufacturing site to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW PICC SET: 16 GA X 27 1/2IN
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17994777
• Report Number: 9680794-2023-00835
• Device Sequence Number: 20552234
• Product Code: LJS
• UDI-Device Identifier: 10801902094220
• UDI-Public: 10801902094220
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K042126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: AJ-01671
• Device Lot Number: 14F22C0294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2023
• Supplement Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 11/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown